NCT06067841

Brief Summary

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate Cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
64mo left

Started Oct 2023

Longer than P75 for phase_1

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Oct 2023Jul 2031

First Submitted

Initial submission to the registry

September 28, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

October 18, 2023

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2029

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2031

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

5.9 years

First QC Date

September 28, 2023

Last Update Submit

February 2, 2026

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

Prostate CancerCastration-resistant prostate cancerAdenocarcinoma of the prostateProstatic Neoplasms Castration-ResistantNeoplasms

Outcome Measures

Primary Outcomes (5)

  • Number of participants with adverse events (AEs)

    Up to 112 weeks

  • Number of participants with serious adverse events (SAEs)

    Up to 112 weeks

  • Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria

    Up to 28 days

  • Number of participants with AEs leading to study intervention discontinuation

    Up to 104 weeks

  • Number of deaths

    Up to 108 weeks

Secondary Outcomes (6)

  • Maximum concentration (Cmax)

    Up to 13 weeks

  • Time of maximum concentration (Tmax)

    Up to 13 weeks

  • Area under the plasma concentration-time curve (AUC)

    Up to 13 weeks

  • Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate

    Up to 108 weeks

  • Number of participants with soft tissue response

    Up to 108 weeks

  • +1 more secondary outcomes

Study Arms (1)

Administration of BMS-986460

EXPERIMENTAL
Drug: BMS-986460

Interventions

BMS-986460DRUG

Specified dose on specified days.

Administration of BMS-986460

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  • Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL at Screening
  • Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)

You may not qualify if:

  • Participant must not have history of brain metastases.
  • Participant must not have impaired cardiac function or clinically significant cardiac disease.
  • Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Stanford Cancer Center

Palo Alto, California, 94304, United States

RECRUITING

Florida Cancer Specialists Sarasota Drug Development Unit

Sarasota, Florida, 34232, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

Local Institution - 0006

San Antonio, Texas, 78229, United States

WITHDRAWN

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsProstatic Neoplasms, Castration-ResistantNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 5, 2023

Study Start

October 18, 2023

Primary Completion (Estimated)

August 24, 2029

Study Completion (Estimated)

July 27, 2031

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations

US(8)